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Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for its inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for primary immunization in adults 18 to 50 years of age.
MHRA found that VLA2001 meets the required safety, quality and effectiveness standards.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, "We are extremely pleased with this new authorization and would like to thank the MHRA for their trust and confidence. VLA2001 is the only inactivated whole virus COVID-19 vaccine approved in the UK and this authorization could pave the way for the availability of an alternative vaccine solution for the UK population. We continue to receive messages every day from people who are looking for a more traditional vaccine approach. We believe that this new approval could also lead to additional marketing authorizations in other regions of the world. I would like to personally thank all the people who have been supporting us in this endeavor and our internal teams for all their hard work."
This new marketing authorization comes in addition to the emergency use authorization which was granted by the Bahraini NHRA in March 20221. A rolling review process is still ongoing with the European Medicines Agency (EMA). In the UK, following termination of the supply agreement with the British government in September 20212, Valneva is currently in discussion with the Scottish government to supply up to 25,000 doses to the National Health Service and frontline workers in Scotland34.
